FDA: Stalevo may increase male patients’ risk of cancer

SILVER SPRING, Md. Data from a long-term clinical trial may indicate a possible cancer risk in men taking a drug for treating Parkinson’s disease, the Food and Drug Administration said Wednesday.

The agency notified healthcare professionals and patients that it was evaluating data from the STRIDE-PD trial indicating a possible risk of prostate cancer in patients taking the Novartis drug Stalevo (carbidopa, levodopa and entacapone). It cautioned, however, that it had not concluded that a risk existed and that other clinical trials evaluating Stalevo and a related drug, Comtan (entacapone), did not show an increased prostate cancer risk.

Novartis issued the following statement in response to the FDA report: “Novartis is coordinating with the FDA as it evaluates data from the STRIDE-PD study related to an unexpected imbalance in reports of prostate cancer cases. STRIDE-PD was conducted in patients with early Parkinson’s disease to investigate a potential new indication outside the terms of the current label. Previous controlled clinical trials have not found an increased risk of prostate cancer.”

Stalevo and Comtan had collective sales of $217 million in 2009, according to Novartis financial reports.

PRINCETON, N.J. A study published online in the journal Diabetes Care indicated that a once-daily diabetes drug made by Novo Nordisk “further improves” blood sugar control and weight loss when patients switch to it from a competitor made by Eli Lilly, Novo Nordisk announced Tuesday.

The study, conducted by the Danish drug maker, was a 26-week study in Type 2 diabetes patients taking Novo Nordisk’s Victoza (liraglutide) or Lilly’s twice-daily Byetta (exenatide). The drugs are the only glucagon-like peptide-1, or GLP-1 agonists available on the market.

“Clinical benefits were seen in patients who switched from exenatide to Victoza,” University of North Carolina School of Medicine Diabetes Care Center director and study investigator John Buse said. “The significant improvements in blood sugar lowering and fasting glucose confirm the original findings of the trial regarding the efficacy of Victoza.”

Hospira completes Orchid acquisition

LAKE FOREST, Ill. Hospira has completed its $400 million acquisition of the generic injectables business of Orchid Chemicals & Pharmaceuticals, the generic drug maker announced Tuesday.

“We are excited to acquire new capabilities that will create opportunities for commercial growth, position us strongly in a key antibiotics product area, expand our global footprint and enhance our ability to provide lower-cost, high-quality products to patients,” Hospira COO Terry Kearney said. “We’re also excited to welcome a talented base of 450 employees, including newly appointed managing director [for] Hospira India, Dr. C.B. Rao, who joins us with a wealth of diversified industrial and management experience, and will provide continuity of leadership for the Orchid team joining Hospira.”

The acquisition, announced in February, includes Orchid’s beta-lactam antibiotic formuatlions manufacturing complex — comprising penicillin, cephalosporin and carbapenem facilities — and a pharmaceutical research and development facility in Irungattukottai, Chennai.

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Amneal also launched five other products in addition to sevelamer carbonate:

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